MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 YST TEST KIT

Catalog Number	21343
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported a misidentification of cryptococcus neoformans as rhodotorula minuta in association with the vitek® 2 yeast (yst) test kit (lot 2430420103).Repeat testing was not performed and the cryptococcus neoformans identification was obtained via pcr.The customer indicated there was greater than 24 hours for reporting results due to the testing performed at a reference lab.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) reported a misidentification of cryptococcus neoformans as rhodotorula minuta in association with the vitek® 2 yeast (yst) test kit (lot 2430420103).An internal biomérieux investigation was performed using a strain submitted by the customer.The submitted strain was subcultured and testing included vitek yst cards from the two (2) customer lots (2430398223, 2430420103) and a random lot (2430603203) in duplicate, as well as testing with the vitek® ms.The six (6) vitek yst cards tested resulted in a slashline identification of rhodotorula glutinis/mucilaginosa/c.Laurentii with one (1)card, acceptable identification of rhodotorula minuta with two (2)cards, low discrimination identification of r.Glutinis/mucilaginosa/minuta/c.Laurentii with two (2) cards, and low discrimination c.Terreus/r.Minuta with the remaining vitek yst card; thus, duplicating the reported misidentification.Vitek ms resulted in the final identification of cryptococcus neoformans, with a 99.9% confidence value.A review of the customer's rhodotorula minuta data ((b)(6) 2017) demonstrated nine (9) atypical negative reactions (dgala, dglua, dmala, dmnea, irhaa.Dsora, saca, dtura, dgata) for an identification of c.Neoformans according to the vitek yst knowledge base.A review of the slashline rhodotorula glutinis/mucilaginosa/c.Laurentii data ((b)(6) 2017) demonstrated two (2) atypical positive reactions (imlta, isbea) and 10 atypical negative reactions (dgala, dglua, dmala, dmnea, irhaa.Dsora, saca, dtura, iglta, dxyla) for an identification of c.Neoformans according to the vitek yst knowledge base.An increased number of atypical reactions can indicate a strain with decreased viability, contamination, or mixed culture.This issue involves an atypical strain.

• Brand Name: VITEK® 2 YST TEST KIT
• Common Device Name: VITEK® 2 YST TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7373988
• Report Number: 1950204-2018-00120
• Device Sequence Number: 11055891
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2019
• Device Catalogue Number: 21343
• Device Lot Number: 2430420103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1